A comparison of immunogenicity and safety of indigenously developed liquid (DTwPHB-Hib) pentavalent combination vaccine (Shan 5) with Easyfive (liq) and TritanrixHB + Hiberix (lyo) in Indian infants administered according to the EPI schedule
| Autor: | Raman K. Rao, Vinoo Tibrewala, Mandeep S. Dhingra, Padmanabha Maiya, Sandeep B Bavdekar, Pravakar Mishra, Raju C Shah, Narendra Behera, Ritabrata Kundu, Arul Mani Rajamani, Shaloo Pandhi, A. K. Dutta, Subhash R Daga, Sankaranarayan Shuba |
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| Rok vydání: | 2009 |
| Předmět: |
Male
medicine.medical_specialty Drug-Related Side Effects and Adverse Reactions Fever Immunology Immunization Secondary India Pain Skin Diseases Combination vaccines law.invention Randomized controlled trial law Internal medicine Injection site medicine Humans Hepatitis B Vaccines General Pharmacology Toxicology and Pharmaceutics Hepatitis B Antibodies Adverse effect Diphtheria-Tetanus-Pertussis Vaccine Haemophilus Vaccines biology business.industry Immunogenicity Infant Antibodies Bacterial Surgery Immunoglobulin G biology.protein Female Mild fever Antibody business |
| Zdroj: | Human vaccines. 5(6) |
| ISSN: | 1554-8619 |
| Popis: | The study was planned to assess and compare the immune response and safety of an indigenous DTPwHB-Hib pentavalent liquid combination vaccine (Shan 5) with Easyfive and TritanrixHB+ Hiberix, the two available pentavalent combination vaccines. Four hundred infants were randomized to receive three doses of either Shan 5 or one of the two comparators. Antibody analysis was performed prior to and four to six weeks post third vaccine dose. Solicited local and systemic events upto three days and unsolicited adverse events in the 30 days follow up period after each dose were recorded. A total of 365 subjects completed the study. Four to six weeks after third dose, 98.32% of the subjects in Shan 5 group had seroprotective Anti PRP-T IgG antibody concentrations (> or =0.15 microg/mL) as compared to 100% and 98.94% subjects in TritanrixHB + Hiberix and Easyfive groups respectively. Seroprotective levels for Anti-HBs (> or =10 mIU/mL) were observed in 97.77%, 97.83% and 98.94% subjects in Shan 5, TritanrixHB + Hiberix and Easyfive groups respectively. Comparable immune responses were observed for the three other components (D, T and P) in all the groups. Four Serious Adverse Events (SAEs) were reported (three with Shan 5 and one with Easyfive), all unrelated to the respective vaccines. Most commonly reported adverse events in all the groups were pain at injection site, mild fever ( |
| Databáze: | OpenAIRE |
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